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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05231837
Other study ID # STUDY00012450
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date February 15, 2022
Est. completion date June 30, 2026

Study information

Verified date April 2024
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate a park-level intervention to increase child moderate/vigorous physical activity (MVPA), and decrease sedentary time among low-income racially/ethnically diverse children ages 6-12 yrs. Neighborhood parks (n=20) from Minneapolis (n=8) and Saint Paul (n=12) park systems will be randomized for a 2-year period to one of two arms: 1) Intensive Park Outreach and Youth Sports Program Fee Waiver (n=10); or 2) Youth Sports Program Fee Waiver Only (n=10). The evaluation cohort will consist of 432 children ages 6-12 yrs who reside in one of the 20 randomized park neighborhoods. Measurements from evaluation cohort-enrolled individual children will be collected at baseline, 6, 12, and 24 months.


Description:

This research evaluates the effects of a park-level intervention to increase child moderate/vigorous physical activity (MVPA), and decrease sedentary time among low-income racially/ethnically diverse children ages 6-12 yrs. Neighborhood parks (n=20) from Minneapolis (n=8) and Saint Paul (n=12) park systems will be randomized for a 2-year period to one of two arms: 1) Intensive Park Outreach and Youth Sports Program Fee Waiver (n=10); or 2) Youth Sports Program Fee Waiver Only (n=10). In the Intensive Park Outreach and Youth Sports Program Fee Waiver condition, Community Advisory Boards (CABs) will be created to develop partner networks that will publicize the free youth park programs offered at the local park and recreation center. CABs will engage in program recruitment activities throughout the study to directly engage parents to support their child's PA through enrollment and participation in youth sports park programs. Parents will be supported through CAB outreach activities that address cultural and communication barriers, and financial barriers will be addressed through the fee waiver program. The Youth Sports Program Fee Waiver Only will consist of financial supports through the fee waiver, but will not include additional outreach beyond usual park outreach activities. The evaluation cohort will consist of 432 children ages 6-12 yrs who reside in one of the 20 randomized park neighborhoods. Measurements from evaluation cohort-enrolled individual children will be collected at baseline, 6, 12, and 24 months. The Specific Aims of this research are: Specific Aim 1: To evaluate the effects of a park-level intervention on changes in child MVPA over 6, 12 and 24 months. Specific Aim 2: To evaluate the effects of a park-level intervention on changes in child sedentary behavior over 6, 12 and 24 months. Exploratory Aim 3: To evaluate the effects of a park-level intervention on changes in parent light and sedentary activity over 6, 12 and 24 months. Hypothesis 1: Children who live in a neighborhood where the park is randomized to intensive park outreach and fee waiver will have larger increases in MVPA and decreases in sedentary behavior at 6, 12 and 24 months relative to children who live in a fee waiver-only neighborhood. Hypothesis 2: Parents of children who live in a neighborhood where the park is randomized to intensive park outreach and fee waiver will have larger increases in light PA and decreases in sedentary behavior at 6, 12, and 24 months relative to parents of children who live in a fee waiver-only neighborhood. IMPACT: The proposed research will provide evidence about the effectiveness of a park-based intervention that includes intensive park outreach and youth sports program fee waivers on changes in physical activity among racially/ethnically diverse children with low-income. It will provide critical information needed to support policies and programs that increase the reach and participation of children living in high-risk, low income communities, and thereby reduce racial/ethnic and income-related physical activity disparities.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 435
Est. completion date June 30, 2026
Est. primary completion date April 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - age 6-12 years - do not meet guidelines for recommended level of physical activity - live in neighborhood served by one of 20 study parks - able to be physically active - do not plan to move in the next two years Exclusion Criteria: - younger than 6 or older than 12 years of age - do not live within 2 miles of study park - already meet physical activity guidelines - not able to be physically active plan to move within two years

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Experimental: Fee Waiver
Fees are waived for youth sports programs at the park and recreation center
Fee Waiver Plus Intensive Outreach
Fees are waived for youth sports programs at the park and recreation center and intensive outreach is conducted in the neighborhood through community advisory boards and partner engagement.

Locations

Country Name City State
United States University of Minnesota Division of Epidemiology & Community Health Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Minutes per day of moderate and vigorous physical activity Accelerometers worn for 7 day calculate minutes per day of moderate and vigorous physical activity two years
Primary Minutes per day of light and sedentary activity Accelerometers worn for 7 days calculate minutes per day of light and sedentary activity two years
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